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Trial · Interventional

CompletedPhase 4Registry data

Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Mar 2006
Primary completion
Jan 2010
Completion
Not stated
First posted
14 Sept 2006 (estimated)
Last update posted
6 Mar 2017
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 4

    Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

    NCT00376064

    Mar 2006 to Jan 2010 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy

Interventions

  • Octreotide acetate and cabergoline/Octrotide and SomavertDrug

Arms1

  • Experimental

    SMS995 + Carbegolin, Somavert + SMS995

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

    Time frame · 8 months

Secondary outcomes(5)
  1. Effect of tumor size

    Time frame · 8 months

  2. Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values

    Time frame · 8 months

  3. Control clinical of symptoms of acromegaly

    Time frame · 8 months

  4. Quality of Life assessment

    Time frame · 8 months

  5. Safety and tolerability as assessed by frequency of AEs

    Time frame · 8 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Male and female patients (\> 18 years) with prior surgery of micro- or macroadenoma of the pituitary. * At least 6 months chronic treatment with 30mg octreotide (long acting release). * Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used. * Lack of suppression of GH nadir to \< 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient. * Patient's written informed consent. Exclusion criteria: * Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass. * Radiotherapy planned or radiotherapy for acromegaly within the last 2 years. * Symptomatic cholelithiasis that is clinically relevant. * Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists. * Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis. Other protocol-defined inclusion/exclusion criteria may apply

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